Denver Solutions, LLC DBA Leiters Health recalls PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Comp
Recalled February 7, 2024 · FDA recall D-0279-2024 · Denver Solutions, LLC
Hazard
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags. · FDA Class I
Units
29,016 IV bags
Sold at
Nationwide within the United States
Description
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Product
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC 71449-148-94.
Manufacturer(s)
Denver Solutions, LLC DBA Leiters Health
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →